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Saving Access to Compounded Medications for Special Needs Patients Act

Mon, 06/01/2015 - 20:46

Senator Vitter Proposes to Tweak Statute to Explicitly Permit Office Use Compounding As Permitted Under State Law and to Eliminate “Addressing Inordinate Amounts” in FDA’s MOU with States

Senator David Vitter (R-LA) introduced S. 1406, the Saving Access to Compounded Medications for Special Needs Patients Act, to amend Section 503A of the Federal Food, Drug, and Cosmetic Act. The amendment addresses confusion over a compounding pharmacy’s “distribution” of compounded preparations and, specifically, compounding for office use (i.e., compounding preparations that are not based on a prescription for an individually identified patient). As with other provisions of Section 503A, the amendment would exempt compounding pharmacies from the new drug (Section 505), adequate directions for use (Section 502(f)(1)), and current good manufacturing (cGMP) requirements (Section 501(a)(2)(B)) if the drug product is “compounded and distributed to a practitioner where, as permitted under State law, the drug product is used in the treatment of or administered to a patient of the practitioner....” The proposed provision addresses what many believe is a battle between FDA, various states, and an oversight on the part of Congress concerning office use compounding - as permitted by state law (based on the legislative history concerning re-enactment of Section 503A as part of the passage of Title I of the Drug Quality and Security Act in November2013).